Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

NCT ID: NCT00689104

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-28
• Study Completion Date: 2009-03-24

Brief Summary

The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

Conditions

Urinary Bladder, Overactive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo to Mirabegron

Intervention Type: DRUG

Matching mirabegron placebo tablets.

Placebo to Tolterodine

Intervention Type: DRUG

Matching tolterodine placebo capsules.

Mirabegron 50 mg

Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.

Group Type: EXPERIMENTAL

Mirabegron

Intervention Type: DRUG

Tablets

Placebo to Tolterodine

Intervention Type: DRUG

Matching tolterodine placebo capsules.

Mirabegron 100 mg

Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.

Group Type: EXPERIMENTAL

Mirabegron

Intervention Type: DRUG

Tablets

Placebo to Tolterodine

Intervention Type: DRUG

Matching tolterodine placebo capsules.

Tolterodine SR 4 mg

Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Tolterodine

Intervention Type: DRUG

Capsules

Placebo to Mirabegron

Intervention Type: DRUG

Matching mirabegron placebo tablets.

Interventions

Mirabegron

Tablets

Intervention Type: DRUG

Tolterodine

Capsules

Intervention Type: DRUG

Placebo to Mirabegron

Matching mirabegron placebo tablets.

Intervention Type: DRUG

Placebo to Tolterodine

Matching tolterodine placebo capsules.

Intervention Type: DRUG

Other Intervention Names

Myrbetriq; YM178

Eligibility Criteria

Inclusion Criteria

• Subject is willing and able to complete the micturition diary and questionnaires correctly
• Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
• Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
• Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period

Exclusion Criteria

• Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
• Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
• Subject has an indwelling catheter or practices intermittent self-catheterization
• Subject has diabetic neuropathy
• Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
• Subject receives non-drug treatment including electro-stimulation therapy
• Subject has severe hypertension
• Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
• Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
• Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
• Subject has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) > 3x ULN
• Subject has a clinically significant abnormal electrocardiogram (ECG)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

Auchenflower, , Australia

Clayton, , Australia

Kogarah, , Australia

Randwick, , Australia

Woolloongabba, , Australia

Graz, , Austria

Innsbruck, , Austria

Linz, , Austria

Minsk, , Belarus

Minsk, , Belarus

Minsk, , Belarus

Antwerp, , Belgium

Antwerp, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Edegem, , Belgium

Ghent, , Belgium

Kortrijk, , Belgium

Leper, , Belgium

Leuven, , Belgium

Liège, , Belgium

Sint-Truiden, , Belgium

Pleven, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Brno, , Czechia

Mělník, , Czechia

Olomouc, , Czechia

Ostrava-Poruba, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Štětí, , Czechia

Ústí nad Labem, , Czechia

Aalborg, , Denmark

Aarhus, , Denmark

Glostrup Municipality, , Denmark

Roskilde, , Denmark

Helsinki, , Finland

Oulu, , Finland

Tampere, , Finland

Turku, , Finland

Bordeaux, , France

Colmar, , France

Marseille, , France

Marseille, , France

Mulhouse, , France

Nantes, , France

Nîmes, , France

Orléans, , France

Paris, , France

Paris, , France

Rouen, , France

Saint-Priest-en-Jarez, , France

Strasbourg, , France

Toulouse, , France

Aichach, , Germany

Bad Ems, , Germany

Bautzen, , Germany

Berlin, , Germany

Duisburg, , Germany

Eisleben Lutherstadt, , Germany

Frankfurt, , Germany

Ganderkesee, , Germany

Hagenow, , Germany

Halle, , Germany

Hamburg, , Germany

Henningsdorf, , Germany

Hettstedt, , Germany

Koblenz, , Germany

Leipzig, , Germany

Muenchen-Bogenhausen, , Germany

Neustadt in Sachsen, , Germany

Oranienburg, , Germany

Radebeul, , Germany

Sangerhausen, , Germany

Trier, , Germany

Uetersen, , Germany

Athens, , Greece

Nikaias-Piraeus, , Greece

Pátrai, , Greece

Thessaloniki, , Greece

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Eger, , Hungary

Nyíregyháza, , Hungary

Pápa, , Hungary

Sopron, , Hungary

Szeged, , Hungary

Szekszárd, , Hungary

Székesfehérvár, , Hungary

Tatabánya, , Hungary

Veszprém, , Hungary

Reykjavik, , Iceland

Cork, , Ireland

Dublin, , Ireland

Mullingar, , Ireland

Tralee, , Ireland

Bari, , Italy

Catanzaro, , Italy

Florence, , Italy

Florence, , Italy

Genoa, , Italy

Latina, , Italy

Magenta, , Italy

Milan, , Italy

Milan, , Italy

Modena, , Italy

Naples, , Italy

Perugia, , Italy

Teramo, , Italy

Treviglio, , Italy

Varese, , Italy

Liepāja, , Latvia

Riga, , Latvia

Kaunas, , Lithuania

Vilnius, , Lithuania

Amsterdam, , Netherlands

Apeldoorn, , Netherlands

Apeldoorn, , Netherlands

Eindhoven, , Netherlands

Enschede, , Netherlands

Leiden, , Netherlands

Maastricht, , Netherlands

Nijmegen, , Netherlands

Sneek, , Netherlands

Tilburg, , Netherlands

Winterswijk, , Netherlands

Bergen, , Norway

Drammen, , Norway

Hamar, , Norway

Oslo, , Norway

Tønsberg, , Norway

Bialystok, , Poland

Chorzów, , Poland

Lodz, , Poland

Lodz, , Poland

Lublin, , Poland

Warsaw, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Amadora, , Portugal

Porto, , Portugal

Tomar, , Portugal

Viana do Castelo, , Portugal

Bucharest, , Romania

Bucharest, , Romania

Lasi, , Romania

Oradea, , Romania

Timișoara, , Romania

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Martin, , Slovakia

Poprad, , Slovakia

Skalica, , Slovakia

Trenčín, , Slovakia

Žilina, , Slovakia

Bloemfontein, , South Africa

Hatfield, , South Africa

Lyttelton, , South Africa

Paarl, , South Africa

Pietermaritzburg, , South Africa

Barcelona, , Spain

Bilbao, , Spain

Esplugues de Llobregat-Barcelo, , Spain

Fuenlabrada, , Spain

Getafe, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Mataró, , Spain

Miranda de Ebro, , Spain

Palma de Mallorca, , Spain

Seville, , Spain

Toledo, , Spain

Valencia, , Spain

Villarreal de Huerva, , Spain

Borås, , Sweden

Helsingborg, , Sweden

Örebro, , Sweden

Skövde, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Umeå, , Sweden

Uppsala, , Sweden

Frauenfeld, , Switzerland

Lucerne, , Switzerland

Kiev, , Ukraine

Kiev, , Ukraine

Birmingham, , United Kingdom

Chorley, , United Kingdom

Croydon, , United Kingdom

Liverpool, , United Kingdom

London, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Newcastle upon Tyne, , United Kingdom

Northwood, , United Kingdom

Reading, , United Kingdom

Reading, , United Kingdom

Sheffield, , United Kingdom

Swansea, , United Kingdom

Countries

Australia; Austria; Belarus; Belgium; Bulgaria; Czechia; Denmark; Finland; France; Germany; Greece; Hungary; Iceland; Ireland; Italy; Latvia; Lithuania; Netherlands; Norway; Poland; Portugal; Romania; Russia; Slovakia; South Africa; Spain; Sweden; Switzerland; Ukraine; United Kingdom

References

Khullar V, Amarenco G, Angulo JC, Cambronero J, Hoye K, Milsom I, Radziszewski P, Rechberger T, Boerrigter P, Drogendijk T, Wooning M, Chapple C. Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 6.

Reference Type: BACKGROUND

PMID: 23182126 (View on PubMed)

Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Reference Type: DERIVED

PMID: 37160401 (View on PubMed)

Desroziers K, Aballea S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.

Reference Type: DERIVED

PMID: 24246044 (View on PubMed)

Related Links

https://www.astellasclinicalstudyresults.com/study.aspx?ID=35

Link to results on Astellas Clinical Study Results website

Other Identifiers

2007-001451-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

178-CL-046

Identifier Type: -

Identifier Source: org_study_id